Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation

Completed

• Conditions: Simulated Pediatric CRP Ventilation
• Interventions: Other: cardiopulmonary resuscitation (CPR)

• Registration Number: NCT05345704
• Lead Sponsor: Brno University Hospital

Brief Summary

The aim of this study is to gather data to support beginning the pediatric cardiopulmonary resuscitation (CPR) with 5 initial breaths. The group of health care professionals and the group lay rescuers will be asked to perform cardiopulmonary resuscitation (CRP) on 2 pediatric simulation mannequins (the 3-month-old infant, 5 kg, and the 5-year-old child, 25 kg) and the effectiveness of initial ventilation attempts will be evaluated.

Detailed Description

There is a lack of knowledge on the efficiency of ventilation during simulated and real cardiopulmonary resuscitation of children and infants. The ventilations should be an integral part of pediatric resuscitation as recommended by European Resuscitation Council (ERC) because the respiratory and other secondary causes with oxygen depletion are common causes of cardiac arrest in children. However, the effectiveness and quality of ventilation are rarely studied and ERC guidelines to start ventilation with 5 initial breaths in pediatric CPR are based on the experts´ opinion. This study evaluates ventilation efficiency during simulated pediatric cardiopulmonary resuscitation performed by 2 different groups of potential rescuers - physicians, nurses- representing the advanced life support and lay rescuers- representing the basic life support algorithm. The primary aim of this study is to evaluate the number of effective breaths (define as a visible chest rise) during 5 initial breaths attempts of simulated pediatric cardiopulmonary resuscitation. Secondary outcomes include subanalysis of the effectiveness of two initial breaths attempts, defined as a visible chest rise, time to first effective breath, breath volume delivered during 5 initial breaths, and breaths during CPR. The appropriate volume would be considered 6-10 mL/kg (i.e. 30 - 50 mL in infant and 125- 250 mL in the child). The data will be obtained before and after standardized simulation training in both groups. For lay rescuers, the dispatcher-assisted CPR will be simulated. For the health care professionals, basic equipment will be available and expected to be used (correct size mask and bag-mask ventilation).

Study Timeline

• Study First Submitted: 2022-04-10
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-26
• Study Start: 2022-04-28
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Volunteer participants - lay rescuers
• Health care professionals performing simulated CPR

Exclusion Criteria

• not willing to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health care professionals (HCPs)	cardiopulmonary resuscitation (CPR)	Health care professionals (HCPs) trained in advanced life support
Lay rescuers	cardiopulmonary resuscitation (CPR)	Volunteer participants in a role lay rescuers

Primary Outcome Measures

Name	Time	Method
Initial ventilation effectivity	During 90 seconds of life support	Number of ventilations that are effective out of the first 5 attempts in each group. Defined as breath that has the ability to elevate the chest

Secondary Outcome Measures

Name	Time	Method
Delay in ventilation	During 90 seconds of life support	Time to first effective ventilation
Initial 2 breaths effectivity	During 90 seconds of life support	Number of effective ventilation from first 2 ventilation attempts in each group
Initial ventilation adequacy	During 90 seconds of life support	Number of ventilations with correct volumes (6-8 mL/kg) out of the first 5 attempts
Ventilation volume during initial breaths	During 90 seconds of life support	Percentage of correct volume breaths during CPR
Delay in CPR	During 90 seconds of life support	Time to start of chest compressions
CPR description	During 90 seconds of life support	Number of CPR cycles (15 compressions: 2 ventilations) during 90 seconds of simulated CPR

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, South Moravian Region, Czechia